cGMP Manufacturing


For over 40 years Avanti has provided API (Active Pharmaceutical Ingredient) Technology Development for Pharmaceutical and Biotechnology companies. Our unique reputation for quality in the development of pre-clinical and clinical candidates is well established. Our full range of services include process chemistry, scale-up manufacturing, supply chain management with analytical and regulatory requirements. Avanti’s experienced staff of chemists and lipid analysts are ready to meet your development needs with pre-clinical through phase III and commercial launch.


Avanti Polar Lipids, Inc. operates FDA inspected and approved facilities, which consist of a total of
80,000 sq/ft in five buildings on our campus, and include:

  • Synthetic Organic Laboratories for product development
  • Formulation Development and Manufacturing
  • cGMP Manufacturing for API production
  • cGMP Adjuvant production
  • cGMP Analytical Laboratories for product testing and stability studies

Avanti’s facilities and range of services are well suited for lipids and hydrophobic small molecule API Technology Development from pre-clinical through phase III, and API commercial manufacturing for approved drug products.

The Avanti Focus

Avanti will establish a Development Team to ensure the smooth API development you need. Our experienced organic chemists will oversee the process development and scale-up while our lipid analysts guarantee that Avanti quality prevails at each step. A typical development path might include:

  • Synthetic process development
  • Synthetic scale-up developments (non-cGMP and cGMP)
  • Analytical development and validation
  • Full scale cGMP manufacturing with process validation
  • IND/NDA regulatory support and commercial launch


  • Synthetic Phospholipids
  • Synthetic Sphingolipids
  • Cationic Lipids
  • PEG-Lipid Conjugates
  • Synthetic Neutral Lipids
  • Synthetic Cholesterol
  • Synthetic Adjuvants
  • Contract Manufacturing of Proprietary Lipid Compounds